- Ensuring Consistent Quality
Compliance with EN-ISO 13485, the internationally recognized standard for medical device quality management systems, ensures that every product we manufacture meets rigorous quality requirements. This guarantees our customers receive sterilization reels and gowns that are safe, effective, and consistent, minimizing risks during medical procedures.
- Maintaining a Controlled Manufacturing Environment
Our production processes occur in an ISO-8 Clean Room, a controlled environment designed to limit contamination and ensure optimal hygiene. This is critical for medical products, as it ensures that the sterilization reels and gowns meet the highest sterility standards, reducing the risk of infection for patients and healthcare workers.
- Offering Safety and Efficacy
Our products meet the EN 13795 standard, specifically developed for surgical drapes, gowns, and clean-air suits. This ensures that our sterile gowns provide excellent barrier protection, breathability, and comfort, safeguarding healthcare professionals during critical procedures. Additionally, our sterilization reels comply with EN 11607, which ensures they maintain sterility and integrity during storage and transport, offering peace of mind to customers.
- Regulatory Assurance with CDSCO MD-5 and MD-14 Licenses
Our CDSCO MD-5 and MD-14 licenses, issued by the Central Drugs Standard Control Organization, validate that our products meet stringent Indian regulatory requirements for medical devices. These licenses assure customers that our sterilization reels and gowns are manufactured under strict oversight, ensuring safety, reliability, and compliance with national standards. This is particularly advantageous for healthcare providers operating within India, as it facilitates adherence to local regulations and enhances patient safety.
- International Market Acceptance
The CE certification on our products signifies conformity with European health, safety, and environmental protection standards. For customers, this ensures that our sterilization reels and sterile gowns are not only compliant with regional requirements but also meet global benchmarks, enabling seamless use in various markets.
- Supporting Compliance and Accreditation
Healthcare facilities and organizations are often required to meet strict regulatory and accreditation standards. By choosing our products, which adhere to recognized international norms, our customers can ensure that their own operations remain compliant, facilitating smooth audits and inspections.
- Enhancing Trust and Reliability
When healthcare professionals and institutions choose products with these certifications, they are assured of superior performance, safety, and reliability. Our commitment to maintaining these standards reinforces our dedication to supporting the health and safety of both medical teams and patients.